Upgrade USB Dongle, V. R.1.6

Upgrade USB Dongle, V. R.1.6
Crossfire - 0475000010

An application software program intended to be used as or in an appropriate information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with orthopaedic arthroscopy procedures. It may be used to record arthroscopy treatment chains, to provide treatment effectiveness and quality reports, and to facilitate structured clinical research. It is typically installed into decentralized computers/networks.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: HRX

Device Name: Arthroscope

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 888.1100

Third Party Flag: Y

Medical Specialty: OR

Device Id: 07613327145205

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A